Statistics at a Glance

Statistics
at a Glance

 

This figure shows institution rates for PGRs compared to IPRs[1] for all technologies as well as Orange Book and biologic drug IPRs.  It is noteworthy that compared to the 51% institution rate for PGRs, IPRs have been instituted at a higher rate (65%).  This higher rate is also seen for both Orange Book and biologic drug IPRs.

[1] IPR institution rates are based on PTO data available at: https://www.uspto.gov/patents/ptab/statistics/aia-trial-statistics-archive.

 

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    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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